The Recall Desk
ModerateFDA (Drugs)·D-0026-2026·Announced 2025-10-22

Prescription Drug Recall: Everolimus Tablets Fail Impurity Specification

Endo USA is recalling 1,041 cartons of Everolimus 5mg tablets nationwide due to out-of-specification levels of impurity IP-C. The affected lot (550172301, expiring January 2026) failed quality specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with no reported illnesses, injuries, or deaths. The issue is an out-of-specification manufacturing quality deviation for impurity IP-C. Class III recalls are typically rated as Low or Moderate; this is rated Moderate due to the quality-control nature of the specification failure.

Plain-English summary

Endo USA, Inc. is recalling 1,041 cartons of Everolimus tablets (5mg) due to a manufacturing quality issue. The product failed to meet specifications for impurity IP-C.

The recalled product is Everolimus 5mg tablets in 28-tablet packages (NDC 49884-125-91), manufactured by Par Pharmaceutical Companies, Inc. in Chestnut Ridge, NY. The recalled lot is #550172301 with an expiration date of January 2026. This product was distributed nationwide throughout the United States.

Consumers who have this product should contact their healthcare provider or pharmacy to determine if they are affected by this recall.

The recalled product

Product
EVEROLIMUS (EVEROLIMUS)
Brand
EVEROLIMUS
Manufacturer
Endo USA, Inc.
Category
Drug — Immunosuppressant
Hazard
  • specification-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 550172301
  • Exp. Date January 2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · EVEROLIMUS

Same category